INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo TETAGAM IM 250 IU (solution for intramuscular injection)
TETAGAM IM 500 IU (solution for intramuscular injection)

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form):

TETAGAM IM 250 IU (solution for intramuscular injection)
TETAGAM IM 500 IU (solution for intramuscular injection)

COMPOSITION
Descriptive name:
Human
tetanus immunoglobulin
Tetagam IM contains gammaglobulin derived from pooled human plasma, sourced from non-remunerated healthy donors, with a high titre of antibodies to tetanus toxin.
Each unit of plasma has been individually tested and found non-reactive for hepatitis B surface antigen (HBsAg), antibodies to the hepatitis C virus (HCV) and antibodies to the human immunodeficiency viruses, HIV-1 and HIV-2, using approved methods.
Tetagam IM is prepared by cold ethanol fractionation to further reduce the risk of viral transmission. In addition, only plasma pools tested and found non-reactive for anti-HIV-1 & -2, HBsAg and anti-HCV by serological testing; and for HIV, HCV, hepatitis B virus (HBV) and hepatitis A virus (HAV) by Nucleic Acid Amplification Techniques (NAT), are used in the manufacture of Tetagam IM.
Each ampoule of Tetagam IM 250 IU contains 250 IU (125 IU/mL) tetanus antibodies.
Each ampoule of Tetagam IM 500 IU contains 500 IU (500 IU/mL) tetanus antibodies.
This preparation contains no antimicrobial preservative and is stabilised with glycine.

PHARMACOLOGICAL CLASSIFICATION
A 30.2 Biologicals (Antibodies)

PHARMACOLOGICAL ACTION
Tetanus immunoglobulin confers passive immunity against tetanus.

INDICATIONS
1. Post-exposure prophylaxis
Immediate prophylaxis after tetanus-prone injuries in patients not adequately vaccinated, in patients whose immunisation status is not known with certainty, and in patients with severe deficiency in antibody production.
2. Therapy of clinically manifest tetanus
Active tetanus vaccination should always be administered in conjunction with tetanus immunoglobulin unless there are contra-indications or confirmation of adequate vaccination

IMMUNE STATUS CLEAN MINOR WOUNDS
(Tetanus infection unlikely)
ALL OTHER WOUNDS (Dirty wounds)
  Tetanus immunoglobulin Tetanus toxoid Tetanus immunoglobulin Tetanus toxoid
Unknown No Yes Yes Yes
Incomplete Course of Toxoid No Yes Yes Yes
Complete Course of Toxoid:
Last Booster >10 years ago No Yes Yes Yes
Last Booster 5-10 years earlier No Yes No Yes
Last Booster within past 5 years No No No No
Tetagam IM supplements but does not replace antibiotic therapy.

CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients, including excipients.

WARNINGS
This intramuscular preparation should not be given intravenously because of the risk of shock.
Intramuscular injections are not advocated for patients with bleeding disorders (Refer “Special Precautions”).

INTERACTIONS
Live attenuated virus vaccines
Immunoglobulin administration may interfere with the development of an immune response to live attenuated virus vaccines such as rubella, mumps and varicella for a period of up to 3 months. After administration of this product, an interval of at least 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 5 months.
Interference with serological testing
After injection of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.

PREGNANCY AND LACTATION
The safety of intramuscular immunoglobulin in pregnancy and lactation has not been established in controlled clinical trials. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.

DOSAGE AND DIRECTIONS FOR USE
INDICATIONS DOSE
Prophylaxis:
High risk injuries to non-immune and immune patients
250 IU
(500 IU if 24 hours have passed since injury or if there is a risk of heavy contamination)
Treatment:
Clinical tetanus
3000-6000 IU as a single dose
Tetagam IM may be used to treat clinical tetanus both locally by infiltration into the wound site, as well as intramuscularly

Method of administration
Warm the ampoule to body temperature before injecting intramuscularly.
The usual recommended site for adults is the deltoid; for infants, the lateral aspect of the thigh is preferable.
If a large volume (>2 mL for children or >5 mL for adults) is required, it is recommended that this be administered in divided doses at different sites.
When simultaneous vaccination is necessary, the immunoglobulin and the vaccine should be administered at two different sites to avoid interference with the active antibody response.
This medicinal product must not be mixed with other medicinal products.
Any unused product or waste material should be disposed of in accordance with local procedures.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Side effects
The following undesirable effects have been reported with intramuscular immunoglobulins:
Skin & Appendages: Cutaneous reactions, local reactions
Central & Peripheral Nervous System: Headache, lightheadedness
Gastro-Intestinal System: Nausea
Vascular (Extracardiac): Flushing
Body as a Whole - General: Pain and tenderness at injection site, chills, backache, fever
Special Precautions
Intramuscular injections are not advocated for persons with bleeding disorders, unless special precautions are taken.
True hypersensitivity reactions are rare.
Anaphylactic reactions may occur, especially if this intramuscular preparation is given intravenously. Measures to treat anaphylaxis, including adrenaline, should be immediately available when administering Tetagam IM.
Persons with selective immunoglobulin A (IgA) deficiency may develop antibodies to the small amount of IgA in this preparation, leading to sensitisation and subsequent reaction to IgA-containing material. The risk-benefit ratio in patients with a history of IgA deficiency or severe anaphylactic reactions to plasma products should be considered.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and pathogens.Consideration should be given to appropriate vaccination of patients receiving human blood or plasma-derived medicinal products on a routine basis.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV. The measures taken may be of limited value against non-enveloped viruses such as HAV and parvovirus B19.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to viral safety.
It is strongly recommended that when Tetagam IM is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Effects on ability to drive and use machines
No effects on ability to drive and use machines have been observed.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Consequences of an overdose are not known.

IDENTIFICATION
A colourless, pale yellow to light brown liquid exhibiting slight opalescence.

PRESENTATION
Tetagam IM 250 IU:
2 mL in a single dose, clear, colourless 2 mL glass ampoule.
Tetagam IM 500 IU: 1 mL in a single dose, clear, colourless 2 mL glass ampoule.

STORAGE INSTRUCTIONS
Transport within 72 hours below 37ºC.
Store between 2ºC and 8ºC.
Do not freeze.
Protect from light.
Keep out of reach of children.

REGISTRATION NUMBER
Tetagam IM 250 IU
: T/30.2/743
Tetagam IM 500 IU: T/30.2/744

NAME AND BUSINESS ADDRESS OF THE APPLICANT
NATIONAL BIOPRODUCTS INSTITUTE
Company Reg. No. 1994/002044/08
NPO Reg. No. 020-898-NPO

PRIVATE BAG X9043         10 EDEN ROAD
PINETOWN         PINETOWN
3600         3610
Telephone:        086 016 2472         Telefax:        031 708 5614

DATE OF PUBLICATION OF THIS PACKAGE INSERT
2012/03/26

NAMIBIA         S2
Reg. No.:
Tetagam IM 250 IU:        04/30.2/1142
Tetagam IM 500 IU:        04/30.2/1143

2011/07P55

Updated on this site: August 2014
Source: Pharmaceutical Industry

Disclaimer:
Please note that the National Bioproducts Institute cannot be held responsible for the accuracy of the text. The package insert on the screen may not be the latest version. We therefore recommend that an alternative source of information be consulted, particularly when confirmation of dosages and indications are required. Please refer to the printed package inserts inside the packs, recognised reference books or alternatively, you may contact the NBI Information Centre at +27 (031) 714 6700 or +27 082 870 3705 or +27 082 320 3306
.
Email: info@nbisa.org.za


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